Lead Medical Writer

2 weeks ago

Dedham, Massachusetts, United States Synterex Full time
Job Overview

Salary: Negotiable

Synterex, Inc. is a global consortium comprised of highly skilled clinical development professionals who specialize in medical writing, submission publishing, and clinical science and operations support. We provide both remote and on-site services, emphasizing the delivery of clear, concise, accurate, and fully compliant documentation throughout the drug development lifecycle, from initial phases to post-approval.

We are in search of a detail-oriented, proactive, and collaborative individual to join our medical writing team. The Lead Medical Writer will work closely with various client teams across Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, and Program Management to oversee the planning and creation of high-quality clinical regulatory documents. Responsibilities include producing protocols, publications, study reports, investigator brochures, narratives, and module documents in accordance with client and regulatory agency guidelines, all while adhering to tight deadlines.

Location: Fully remote, with the expectation to attend key meetings on-site with clients as necessary.

Key Responsibilities
  • Oversee the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines.
  • Coordinate contributions from cross-functional client stakeholders and internal resources (e.g., quality control, publishing) to ensure timely document completion.
  • Ensure that document development aligns with relevant client processes, templates, and instructional materials.
  • Act as an authority on the client document management system and related tools, templates, and procedures to facilitate efficient document development.
  • Lead the development of document messaging in collaboration with clients.
  • Analyze data and create preliminary documents to assist in authoring.
  • Plan and conduct kickoff meetings.
  • Facilitate the resolution of review feedback, including planning and leading comment resolution meetings to ensure efficiency.
  • Follow up with team members as necessary to address outstanding review feedback.
  • Ensure consistency across client programs regarding messaging, formatting, and presentation of documents.
  • Conduct literature searches as required.
  • Perform peer quality control reviews as needed.
  • Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management) as necessary.
Qualifications
  • Minimum of 5 years of experience as a medical writer in the CRO, biotech, or pharmaceutical sectors.
  • Bachelor's degree or higher in a relevant field.
  • Experience in Oncology, Infectious Disease, or Vaccine writing is preferred.
  • Proficient in writing clinical study reports, protocols, protocol amendments, investigator brochures, and module documents.
  • Flexibility to work across various therapeutic areas as needed.
  • Experience in developing documents according to established processes and templates.
  • Familiarity with lean authoring methodologies and structured content management.
  • Knowledge of ICH and US regulatory requirements for key clinical and regulatory documents; familiarity with ex-US requirements is a plus.
  • Expertise in Microsoft Word and other Microsoft applications.
  • Experience using document management systems, collaborative authoring tools, and review platforms.
  • Ability to adapt to new tools and technologies as required.
  • Strong capability to work independently and collaboratively under competing priorities.
  • Service-oriented and proactive approach to project management.
  • Excellent conflict resolution and negotiation skills.
  • Comfortable providing insights based on previous experiences.
  • Strong written and verbal communication skills.

Synterex is committed to providing equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

  • Environmental Sustainability Lead

    1 week ago

    Dedham, Massachusetts, United States Michael Page Full time

    Are you an experienced professional in sustainability management?We are seeking a dedicated Environmental Sustainability Lead to join a prominent industrial manufacturing organization. This role is ideal for individuals with over 5 years of experience in sustainability within a manufacturing context and a solid grasp of sustainable development goals (SDGs)...

  • Production Assembler

    2 days ago

    Dedham, Massachusetts, United States AliMed Full time

    Job SummaryWe are seeking a highly skilled and detail-oriented Assembler I to join our team at AliMed, a leading medical products manufacturer and distributor. As a key member of our production team, you will be responsible for assembling medical devices in accordance with specifications, ensuring high-quality products that meet our customers' needs.Key...

  • Assistant General Manager

    7 days ago

    Dedham, Massachusetts, United States Dogtopia Full time

    About DogtopiaDogtopia is a leading provider of dog daycare, boarding, and spa services. We are seeking a highly motivated and organized individual to join our team as an Assistant General Manager - Team Lead.Job SummaryThe Assistant General Manager - Team Lead will assist the General Manager in leading the team and ensuring the highest standards of customer...

  • Medical Office Administrator

    7 days ago

    Dedham, Massachusetts, United States Hebrew SeniorLife Full time

    Job SummaryThe Outpatient Clinic Coordinator is a key member of the Hebrew SeniorLife team, responsible for providing administrative support to our geriatric primary care practices. This role requires a high level of professionalism, excellent communication skills, and the ability to prioritize tasks effectively.Key ResponsibilitiesProvide exceptional...

  • Lead Applied Behavior Analysis Team

    2 weeks ago

    Dedham, Massachusetts, United States Cortica Full time

    Cortica is seeking a dedicated and experienced Applied Behavior Analysis Supervisor (BCBA) to guide our growing team of professionals. As an integral part of our innovative healthcare company, you will play a pivotal role in shaping the lives of children with neurodevelopmental differences. We are committed to providing life-changing care through...

  • Lead Applied Behavior Analysis Supervisor

    4 days ago

    Dedham, Massachusetts, United States Cortica Full time

    About the RoleCortica is seeking an experienced and skilled Applied Behavior Analysis (ABA) Supervisor to join our team. As a key member of our clinical leadership team, you will be responsible for overseeing the development and implementation of ABA programs for children with autism and other developmental differences.Key ResponsibilitiesProgram Development...

  • Center Operations Manager

    1 week ago

    Dedham, Massachusetts, United States American Family Care Full time

    Center Administrator Job OverviewAt American Family Care, we are seeking a highly skilled and dedicated Center Administrator to join our team. As a Center Administrator, you will play a vital role in maintaining a culture of excellence by leading with integrity and upholding high performance standards.Key Responsibilities:Maintain a Clean and Welcoming...

  • Assembler I

    7 days ago

    Dedham, Massachusetts, United States AliMed Full time

    About the RoleWe are seeking a highly skilled and detail-oriented Assembler I to join our team at AliMed, a leading medical products manufacturer and distributor. As a key member of our production team, you will play a critical role in ensuring the quality and efficiency of our products.Key ResponsibilitiesAssemble medical devices and products in accordance...

  • Nurse Practitioner Opportunities

    4 days ago

    Dedham, Massachusetts, United States IntelyCare Full time

    Job SummaryWe are seeking a skilled Registered Nurse to join our team at IntelyCare. As a Registered Nurse, you will be responsible for providing high-quality patient care in a variety of settings, including assisted living facilities, skilled nursing facilities, and other post-acute care environments.Key ResponsibilitiesAdministering nursing care to...

  • Healthcare Professional

    7 days ago

    Dedham, Massachusetts, United States ConvenientMD Full time

    About the Role:The Clinic Nurse is a key member of our clinical team at ConvenientMD, working under the medical direction of our organization. As a lead clinical team member, you will be responsible for guiding and supporting other team members in implementing medical processes and procedures.Key Responsibilities:Conduct patient triage, including vital...

  • Business Operations Manager

    7 days ago

    Dedham, Massachusetts, United States Dogtopia Full time

    About DogtopiaDogtopia is a leading provider of dog daycare, boarding, and spa services. We are seeking an experienced and motivated individual to join our team as an Assistant General Manager - Team Lead.Job SummaryThe Assistant General Manager - Team Lead will assist the General Manager in leading the team and ensuring the highest standards of customer...

  • Nutrition Therapist

    7 days ago

    Dedham, Massachusetts, United States Monte Nido & Affiliates Full time

    Job Summary:We are seeking a skilled Clinical Nutritionist to join our team at Monte Nido & Affiliates. As a Clinical Nutritionist, you will play a crucial role in providing comprehensive nutrition assessments, developing personalized meal plans, and participating in treatment team planning.Key Responsibilities:Conduct comprehensive nutrition assessments for...

  • ABA Supervisor

    23 hours ago

    Dedham, Massachusetts, United States Cortica Full time

    About the RoleCortica is seeking an experienced and skilled ABA Supervisor to join our team. As a key member of our clinical leadership team, you will be responsible for overseeing the clinical programming for patients receiving Applied Behavior Analysis (ABA) Treatment.Key ResponsibilitiesComplete Assessment and Treatment plans following Cortica's clinical...

  • Warehouse Operations Supervisor

    7 days ago

    Dedham, Massachusetts, United States Cummins Full time

    About the RoleWe are seeking a highly skilled Parts Manager to join our team at Cummins, specializing in Service for the Distribution Business Segment. As a key member of our team, you will be responsible for supervising Parts Specialists and warehouse staff, ensuring the efficient management of physical inventory and meeting customer expectations.Key...

  • Nurse Practitioner

    7 days ago

    Dedham, Massachusetts, United States ConvenientMD Full time

    About the Role:The Clinic Nurse is a key member of our clinical team at ConvenientMD, working under the medical direction of our organization. As a lead clinical team member, you will be responsible for guiding and supporting other team members in implementing medical processes and procedures.Key Responsibilities:Conduct patient triage, including vital...

  • Geriatric Care Specialist

    7 days ago

    Dedham, Massachusetts, United States Hebrew SeniorLife Full time

    Job SummaryThe Outpatient Clinic Coordinator is a key member of the Hebrew SeniorLife team, responsible for providing administrative support to our geriatric primary care practices. This role requires a high level of professionalism, excellent communication skills, and the ability to prioritize tasks effectively.Key ResponsibilitiesProvide exceptional...

  • Behavioral Health Program Manager

    7 days ago

    Dedham, Massachusetts, United States Cortica Full time

    About CorticaCortica is a rapidly growing healthcare company that specializes in providing innovative treatment methods for children with neurodevelopmental differences. Our mission is to design and deliver life-changing care that cultivates the full potential of every child.Job SummaryWe are seeking an experienced ABA Clinical Supervisor to join our team....

  • Clinical Director

    5 days ago

    Dedham, Massachusetts, United States Maritime Behavioral Health Management Full time

    Job SummaryWe are seeking a highly skilled and experienced Clinical Director to lead our team at Maritime Behavioral Health Management. As a key member of our senior management team, you will be responsible for the management and quality assurance of all clinical services, including the training and supervision of clinical staff.Key ResponsibilitiesDevelop...

  • Clinical Nutrition Specialist

    7 days ago

    Dedham, Massachusetts, United States Monte Nido & Affiliates, LLC Full time

    **Job Summary**Monte Nido & Affiliates, LLC is seeking a highly skilled Registered Dietitian to join our team in the Inpatient Program at Dedham Center for Recovery. As a Registered Dietitian, you will play a critical role in providing clinical nutrition and meal plans under the supervision of the Director of Clinical Nutrition Services.**Key...

  • Registered Nurse Career Advancement

    6 days ago

    Dedham, Massachusetts, United States IntelyCare Full time

    About the RoleWe are seeking a skilled Registered Nurse to join our team at IntelyCare. As a Registered Nurse, you will be responsible for providing high-quality patient care in a variety of settings, including ALFs, SNFs, and other post-acute care facilities.Key ResponsibilitiesAdministering nursing care to residents and ensuring they receive the right...